QT Variability Pre and Post Cardioversion | NCT00885391

Studies
QT Variability Pre and Post Cardioversion

NCT00885391

Sponsor

Vanderbilt University

Status

Completed

Last Update Posted

Dec 11, 2014Estimated

Enrollment

219Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HL085690-01A2	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Apr 20, 2009

First Submission Date that Met QC Criteria

Apr 21, 2009

First Posted Date

Apr 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2014

Last Update Posted Date

Dec 11, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dawood Darbar, Associate Professor of Medicine and Pharmacology, Vanderbilt UniversityPrincipal Investigator

Lead Sponsor

Vanderbilt UniversityOTHER

Collaborators

Name	Class
National Institutes of Health (NIH)	NIH
Wake Forest University Health Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to learn whether the chemicals in the blood and urine are different when the heart is atrial fibrillation compared to normal sinus rhythm.

Detailed Description

Atrial Fibrillation variably activates the renin-angiotensin-aldosterone system (RAAS), stimulates the sympathetic nervous system, generates oxidant stress, produces natriuretic peptides, and increases ventricular rate. These are interrelated responses and the extent to which these or other pathophysiologic responses determine QT interval during and after Atrial Fibrillation (AF) is unknown. In this study, the QT variability is related to those potential markers in patients with AF undergoing elective DC-cardioversion.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

219Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QT variability before and after direct current cardioversion		1.5

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 21 years of age
Scheduled to undergo an elective DC-Cardioversion of atrial fibrillation or atrial flutter at Vanderbilt University Medical Center

Exclusion Criteria:

Undergoing emergent DC-Cardioversion of atrial fibrillation for hemodynamic instability
Undergoing DC-Cardioversion for post-cardiac surgery
Dual chamber pacemakers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cardiology Clinic Hospital inpatient

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dawood Darbar, M.D., Ph.D., F.A.C.C.	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center		Nashville	Tennessee	37232-0575	United States

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

Not provided